- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00243373
Using Barcode Technology to Improve Medication Safety
Study Overview
Status
Intervention / Treatment
Detailed Description
Patient safety is a critical issue in healthcare1. Medications are the most commonly used form of medical therapy and the single most frequent cause of adverse events2. The medication use process has several stages: ordering, transcribing, dispensing, administering and monitoring. Medication errors have been shown to be common3,4, and a large proportion (61%) of them occur in the dispensing, transcribing and administering stages5. Barcode technology in conjunction with an electronic medication administration record (eMAR) system has been proposed as a promising way to reduce medication errors at the transcribing, dispensing, and administering stages6. However, its efficacy for reducing medication error rates, its acceptance by staff, and its cost-benefit ratio remain unknown. Without evidence to clarify these issues, it is difficult for health care organizations to prioritize this technology among many other potential safety interventions7. We therefore propose to answer 3 related questions in this study: i) What is the impact of barcode and electronic medication administration record (barcode/eMAR) technology on reducing medication errors in hospitalized patients? ii) What is the impact of barcode/eMAR technology on nursing and pharmacy efficiency and satisfaction? iii) Can the cost of barcode/eMAR technology be justified by its benefits? We propose to address these questions at the Brigham and Women's Hospital (BWH), which has a long-standing tradition of innovation in healthcare and research in medication safety. In particular, it was one of the first hospitals to assess the impact of computerized physician order entry (CPOE) on medication safety8,9. While CPOE is important for improving medication safety, it addresses errors primarily in the ordering stage of the medication use process, leaving patients vulnerable to errors that occur at the dispensing, transcribing and administering stages. Therefore, as part of a multi-disciplinary patient safety initiative, BWH has committed 3 million dollars to build a state-of-the-art barcode/eMAR system. This system will include sophisticated decision support to reduce medication errors made beyond the physician ordering stage. Design work is near completion and the hospital plans to implement the system in phases over 9 months beginning in the 4th quarter of 2003. This offers us a window of opportunity to formally study the broad impact of barcode/eMAR technology. We propose to perform a prospective, controlled, multidisciplinary randomized controlled trial of barcode/eMAR's impact on medication errors, as well as evaluations of impact on hospital efficiency, staff satisfaction, and hospital finances.
Specific Aims:
We plan to address the following 3 specific aims over the proposed 24 months of the study:
- To evaluate the impact of barcode/eMAR technology on the rate of serious medication transcribing and administration errors.
- To evaluate the impact of barcode/eMAR technology on nursing workflow and satisfaction in an acute care hospital.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Nurses who agree to be observed during the medication administration process before barcode technology
- Nurses who agree to be observed during the medication administration process after barcode technology is implemented
The goal is 6700 medication administration observations in the pre and the post periods
Exclusion Criteria:
- Nurses who refuse to be observed
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Transcription errors
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Administration errors
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Serious medication errors
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Secondary Outcome Measures
Outcome Measure |
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Nursing satisfaction
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% nursing time spent on medication administration
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ADEs
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tejal Gandhi, MD, Brigham and Women's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HS14053-02
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